Clinical Trials Directory

Trials / Completed

CompletedNCT02780206

Very Low Calorie Diet Weight Loss

Omics Profiling of the Response to Food and Variability of Weight Loss in Medically Supervised Very Low Calorie Diet

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
56 (actual)
Sponsor
Texas A&M University · Academic / Other
Sex
All
Age
30 Years
Healthy volunteers
Not accepted

Summary

Understanding how foods and nutrients are digested, absorbed and metabolized when weight is stable and during weight loss induced by very low calorie diet procedure using the technologies of genomics, transcriptomics, proteomics, metabolomics and fluxomics ("omics") will enable generation of new hypotheses that could explain the inter-individual differences in weight loss and could lead to optimization and individualization of therapies designed to lose weight.

Detailed description

The overarching hypothesis is that there are baseline, pre- and post-diet combinations of 'omics' signatures in response to food and nutrients that explain the weight loss response of obese subjects to the very low calorie (VLC) diet. In order to address the general hypothesis the following specific aims will be addressed: Specific Aim 1: To test the hypothesis that there is a combination of 'omics' parameters in response to a defined meal that discriminate between morbidly obese subjects. Specific Aim 2: To test the hypothesis that variation in % weight loss to the 2-weeks of VLC diet is related to baseline genomic markers, gene expression profile, proteomic and metabolomic signatures as well as baseline metabolic and substrates fluxomics response to a defined meal. Specific Aim 3: To test the hypothesis that variation in % weight loss to the 4-weeks of VLC diet is related to baseline genomic markers, gene expression profile, proteomic and metabolomic signatures as well as baseline metabolic and substrates fluxomics response to a defined meal.

Conditions

Interventions

TypeNameDescription
OTHERStable isotope amino acid infusionsuch as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline

Timeline

Start date
2016-05-01
Primary completion
2018-10-01
Completion
2018-10-01
First posted
2016-05-23
Last updated
2022-02-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02780206. Inclusion in this directory is not an endorsement.